FDA Adverse Event
Malfunction
Summary report: N
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
MDR report key: 1934524
·
Received November 23, 2010
Report
- Report Number
- 2242352-2010-03397
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 13, 2010
- Report Date
- October 25, 2010
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC.
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL MISFIRED. AFTER A F/U CONVERSATION, IT WAS REPORTED THAT MOST LIKELY THERE WAS AN ERROR IN SEAL LOADING. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT IS RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM | PROXIMAL SEAL | DXC | MAQUET CARDIOVASCULAR, LLC. | HSK-3038 | 25018646 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |